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Evaluation of Reproducibility of a Sporozoite Challenge Model for Plasmodium Vivax in Human Volunteers
This study has been completed.
Sponsors and Collaborators: Malaria Vaccine and Drug Development Center
Fundacion Clinica Valle del Lili
Information provided by: Malaria Vaccine and Drug Development Center
ClinicalTrials.gov Identifier: NCT00367380
  Purpose

The study is a randomized open label clinical trial to verify the reproducibility of a sporozoite challenge model for Plasmodium vivax in humans. The verification of the reproducibility of such a model will make it possible to evaluate the efficacy of candidate P. vivax vaccines in Phase 2a trials. The study is divided into two successive steps:

Step A Parasite Blood Donation: Volunteers will be recruited passively from a group of patients who present with active P. vivax infection and accept to donate infected blood. Samples of P. vivax infected blood will be collected and will be screened for infectious diseases, according to standard blood bank procedures. Colonized Anopheles albimanus mosquitoes will be fed with this blood using a Membrane Feeding Assay (MFA). Sixteen (16) days after, selected positive mosquito batches will be used for step B.

Step B Challenge: After informed consent signature, a total of 24 healthy volunteers will be randomly allocated to Groups 1, 2 and 3, of 8 volunteers each and will be challenged with the bite of 3±1, P. vivax infected mosquitoes. Each group will be exposed to a different isolated parasite. Volunteers will be closely monitored post infection, and will be treated as soon as blood infection becomes patent as ascertained by microscopic examination of thick blood smears (TBS). Comparison of data obtained in the three different groups will be used to determine reproducibility of challenge model.

Primary objective: To demonstrate that naïve human volunteers can be safely and reproducibly infected by the bite of An. albimanus mosquitoes carrying P. vivax sporozoites in their salivary glands.

Secondary objective: To determine the influence of the type of parasite isolated on reproducibility and safety of the challenge model with P. vivax in human volunteers

Hypothesis:It is possible to safely develop a reproducible P. vivax infection in human volunteers using P. vivax experimentally infected An. albimanus mosquitoes.


Condition Intervention Phase
Malaria
Fever
SWEATING
Shaking
Chills
Anemia
Drug: Chloroquine phosphate
Drug: Primaquine
Drug: Fansidar (sulfadoxine-pyrimethamine)
Drug: Amodiaquine
Phase II

MedlinePlus related topics: Anemia Fever Malaria
Drug Information available for: Pyrimethamine Sulfadoxine Fansidar Primaquine Primaquine phosphate Amodiaquine Amodiaquine hydrochloride Chloroquine Chloroquine diphosphate Chloroquine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Evaluation of Reproducibility of a Sporozoite Challenge Model for Plasmodium Vivax in Human Volunteers

Further study details as provided by Malaria Vaccine and Drug Development Center:

Primary Outcome Measures:
  • Infections for P. Vivax in 1 year

Estimated Enrollment: 24
Study Start Date: December 2006
Estimated Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, adult male or non-pregnant females (18-45 years of age).
  • Capacity to sign a free informed consent form of participation along with two witnesses.
  • Use of adequate contraceptive method from the initiation of the study until three months after sporozoite challenge.
  • No plans to travel to malaria endemic areas during the course of the study (a year).
  • No plans to travel outside the study area from the 7th day until 31st day after the challenge.
  • Reachable by phone during the whole study period.
  • Able to participate during the whole study period.

Exclusion Criteria:

  • Are less than 18 and over 45 years of age.
  • Are female who is pregnant at serum positive -HCG screening, planning to become pregnant or who is nursing.
  • Have a Duffy negative phenotype.
  • Have a G-6-PD deficiency or any other hemoglobinopathy.
  • Current or past infection with any species of malaria as demonstrated by a positive TBS on screening or history of a documented positive blood smear. P. vivax IFAT of 1
  • Have a known history of allergy to antimalarial drugs or immediate type hypersensitivity reactions to mosquito bites.
  • Clinical or laboratory evidence of significant systemic disease, including hepatic, renal, cardiac, immunologic or hematological disease, HIV positive or have any other known immunodeficiency (including receiving immunosuppressive therapy or a history of splenectomy); infected with hepatitis B or C virus; have a history of autoimmune disease (including inflammatory bowel disease, hemolytic anemia, autoimmune hepatitis, rheumatoid arthritis, lupus, etc.) or connective tissue disease or have any other serious underlying medical condition.
  • Clinically significant laboratory abnormalities as determined by the Investigator(s).
  • Plan to have surgery between enrollment and the end of the challenge follow-up.
  • Previous history of alcoholism or drugs use which interfere with social activities of the volunteer
  • Have any other conditions that are determined by at least two concurring investigators that may interfere with the capacity to provide free and willing informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367380

Locations
Colombia, Valle
Malaria Vaccine and Drug Development Center
Cali, Valle, Colombia, 25574
Sponsors and Collaborators
Malaria Vaccine and Drug Development Center
Fundacion Clinica Valle del Lili
Investigators
Principal Investigator: Socrates Herrera, MD Director
  More Information

Institutional Site  This link exits the ClinicalTrials.gov site
register clinical trials  This link exits the ClinicalTrials.gov site
Organizacion Mundial de la Salud  This link exits the ClinicalTrials.gov site

Publications:
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Arevalo-Herrera M, Herrera S. Plasmodium vivax malaria vaccine development. Mol Immunol. 2001 Dec;38(6):443-55. Review.
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Study ID Numbers: MVDC-2006-004
Study First Received: August 19, 2006
Last Updated: June 15, 2007
ClinicalTrials.gov Identifier: NCT00367380  
Health Authority: Colombia: Fundacion Clinica Valle del Lili;   Colombia: Centro Medico Imbanaco

Keywords provided by Malaria Vaccine and Drug Development Center:
Malaria
Sporozoite
Challenge Model
Plasmodium vivax
Human Volunteers

Study placed in the following topic categories:
Pyrimethamine
Protozoan Infections
Sulfadoxine-pyrimethamine
Amodiaquine
Primaquine
Anemia
Chloroquine
Malaria
Sulfadoxine
Fever
Folic Acid
Chloroquine diphosphate
Parasitic Diseases

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Renal Agents
Antimalarials
Antiparasitic Agents
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Amebicides
Antinematodal Agents
Coccidiosis
Filaricides
Anthelmintics
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Folic Acid Antagonists
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009